Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 24–Apr–2015; updated 29–Apr–2015*
Official Date: 01–May–2016
Expert Committee: Monographs—Excipients
Coordinating Pharmacopoeia: USP
A revision to the harmonized standard for Saccharin Sodium has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Rev. 2 Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the Saccharin Sodium monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.
On April 1, 2015 USP revised General Notices: Section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements via a Revision Bulletin which established January 1, 2018 as the new date of applicability of General Chapters <232> Elemental Impurities—Limits and <2232> Elemental Contaminants in Dietary Supplements. This new date is intended to align the implementation of General Chapter <232> more closely with that of the ICH Q3D Guideline for Elemental Impurities. The implementation of General Chapters <232> and <2232> will coincide with the removal of all references to General Chapter <231> Heavy Metals from monographs and General Chapters in the USP-NF. Accordingly, the reference to General Chapter <231> Heavy Metals in this monograph is omitted with an official implementation date of January 1, 2018, as indicated in the recently revised General Notices. For further details see General Chapter <231> Heavy Metals and Affected Monographs and General Chapters Revision Bulletin.
Changes from the existing USP–NF monograph include:
- In the beginning of the monograph,
- Added the statement: “Portions of this monograph that are national USP text, and are not part of the harmonized text, are marked with symbols to specify this fact.”
- Deleted the “2H2O”, because it is calculated on the anhydrous form.
- Heavy Metals
- Deleted the Heavy Metals test. The official implementation date of this revision is January 1, 2018.
- Readily Carbonizable Substances
- Added the solution preparation for “Matching Fluid A.”
- Acidity or Alkalinity
- Changed the Acceptance criteria from “pink” to “red or pink” for the color.
- Clarity of Solution
- Deleted the “Diluent” and modified the procedure based on the water as solvent/blank.
- Color of Solution
- Deleted the “Diluent A” and changed “Diluent B” to “Diluent.” Modified the procedure based on these changes.
- Added the symbols to the following non-harmonized attributes or local requirements: Identification C, Limit of Toluenesulfonamides, Packaging and Storage, and Labeling.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
The Saccharin Sodium monograph will be incorporated into and become official in USP 39–NF 34.
Should you have any questions about the Saccharin Sodium monograph, please contact Kevin Moore (301-816-8369 or firstname.lastname@example.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or contact Emily Meyer (301-230-7438 or email@example.com).
- Download the Saccharin Sodium monograph – Stage 6
- Download the Saccharin Sodium PDG sign-off documents:
- Previous Stage 6 posting in PF 31 (4), 2005
- Previous Stage 6 posting in PF 31 (2), 2005
- Previous Stage 6 posting in PF 30 (4), 2004
- Previous Stage 6 posting in PF 29 (5), 2003
The Saccharin Sodium monograph that was posted on April 24, 2015 had an incorrect official date of May 1, 2015, instead of May 1, 2016. A corrected version of the PDF was posted on April 29, 2015.